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Also known as VX-147, Inaxaplin
IXP · 6 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| IXP (Inaxaplin) | EXPERIMENTAL | Participants with proteinuric APOL1-mediated kidney disease (AMKD) with or without the comorbidity of Type 2 diabetes mellitus (T2DM) will receive a single dose of IXP once daily, for 13 weeks. |
| Part A (Phase 2/3): VX-147 | EXPERIMENTAL | Participants will be randomized to receive different doses of VX-147. Participants will receive the selected dose of VX-147 for atleast 96 weeks. |
| Part A (Phase 2/3): Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matched to VX-147. |
| Part B (Phase 3): VX-147 | EXPERIMENTAL | Participants who complete Part A will receive VX-147 for an additional 96 weeks. |
| VX-147 | EXPERIMENTAL | All participants received VX-147 at a dosage of 15 mg once daily (qd) for 2 weeks and VX-147 at a dosage of 45 mg qd for 11 weeks. Part A was enrolled in 2 cohorts: Cohort 1 and Cohort 2. Cohort 1 included participants with urine protein to creatinine ratio (UPCR) approximately greater than or equal to (≥) 3 g/g (± 10%) and less than (\<) 10 g/g and estimated glomerular filtration rate (eGFR) approximately ≥30 mL/min/1.73 m2 (± 10%). Cohort 2 included participants with UPCR approximately ≥0.8 g/g (± 10%) and \<2.7 g/g and eGFR approximately ≥30 mL/min/1.73 m2. |
| Cohort 1: Mild Hepatic Impairment | EXPERIMENTAL | Participants will receive a single dose of IXP on Day 1. |
| Cohort 2: Matched Healthy Participants | EXPERIMENTAL | Healthy participants matched to Cohort 1 will receive a single dose of IXP on Day 1. |
| Cohort 3: Moderate Hepatic Impairment | EXPERIMENTAL | Participants will receive a single dose of IXP on Day 1. |
| Cohort 4: Matched Healthy Participants | EXPERIMENTAL | Healthy participants matched to Cohort 3 will receive a single dose of IXP on Day 1. |
| Sequence A: VX-147 | EXPERIMENTAL | Participants will receive VX-147 reference tablet under fasted condition in Treatment Period 1, then VX-147 test tablet under fed condition in Treatment Period 2, and VX-147 test tablet under fasted condition in Treatment Period 3. A washout period of 5 days will be maintained between 3 treatment periods. |
| Sequence B: VX-147 | EXPERIMENTAL | Participants will receive VX-147 test tablet under fed condition in Treatment Period 1, then VX-147 test tablet under fasted condition in Treatment Period 2, and VX-147 reference tablet under fasted condition in Treatment Period 3. A washout period of 5 days will be maintained between 3 treatment periods. |
| Sequence C: VX-147 | EXPERIMENTAL | Participants will receive VX-147 test tablet under fasted condition in Treatment Period 1, then VX-147 reference tablet under fasted condition in Treatment Period 2, and VX-147 test tablet under fed condition in Treatment Period 3. A washout period of 5 days will be maintained between 3 treatment periods. |
| Cohort 1: Severe Renal Impairment | EXPERIMENTAL | Participants will receive a single dose of IXP on Day 1. |
| Cohort 1: Healthy Participants | EXPERIMENTAL | Participants will receive a single dose of IXP on Day 1. |
| Name | Type | Description |
|---|---|---|
| Inaxaplin | DRUG | Tablets for Oral Administration. |
| VX-147 | DRUG | Tablets for oral administration. |
| Placebo | DRUG | Tablets for oral administration. |
| IXP | DRUG | Tablet for oral administration. |
Key Inclusion Criteria: * Participant has an APOL1 genotype of G1/G1, G2/G2, or G1/G2 obtained with a Vertex designated investigational clinical study assay * Estimated Glomerular Filtration Rate (eGFR) of greater than or equal to (≥) 25 milliliter per minute (mL/min)/1.73m\^2 at screening Key Exc...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Apellis Pharmaceuticals, Inc. | APLS | 1 | PHASE2 | APL-2 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE2 | Frexalimab, Brivekimig, rilzabrutinib |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | Atrasentan |
| Akebia Therapeutics, Inc. | AKBA | 1 | PHASE2 | Praliciguat |
| Travere Therapeutics, Inc. | TVTX | 1 | PHASE2 | Sparsentan |
| Vera Therapeutics, Inc. Class A | VERA | 1 | PHASE2 | Atacicept |
IXP, also known as inaxaplin, is an investigational small molecule being developed for focal segmental glomerulosclerosis (FSGS) and renal impairment. It is in Phase 1 clinical development by Vertex Pharmaceuticals Incorporated (VRTX).
IXP, also known as inaxaplin, is being developed by Vertex Pharmaceuticals Incorporated, traded on the NASDAQ under the ticker VRTX. The company is conducting Phase 1 clinical trials to evaluate the drug's pharmacokinetics and safety.
IXP, also known as inaxaplin, is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 studies have been completed, one in participants with renal impairment and one in participants with hepatic impairment.
IXP, also known as inaxaplin, has been studied in two completed Phase 1 clinical trials. NCT05865171 evaluated pharmacokinetics and safety in participants with renal impairment, and NCT06529796 evaluated pharmacokinetics and safety in participants with mild or moderate hepatic impairment.
Yes, IXP is the same as inaxaplin. Both names refer to the same investigational small molecule being developed by Vertex Pharmaceuticals Incorporated for focal segmental glomerulosclerosis (FSGS) and renal impairment.